BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMERICAN ORTHODONTICS

    DI: 00840018600171 · Model: 010-301 · NORDENT MANUFACTURING INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMERICAN ORTHODONTICS
    Primary DI
    00840018600171
    Version / Model
    010-301
    Company Name
    NORDENT MANUFACTURING INC
    Labeler DUNS
    053187985
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-28
    Public Version
    1
    Public Version Date
    2020-05-06
    Public Version Status
    New
    Public Device Record Key
    5b2400eb-2643-431c-bb08-999419af9fa3

    Device Description

    AO USA BAND SEATER N114, DL HEX HANDLE

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    ECR Setter, Band, Orthodontic

    GMDN Terms

    Code Name
    31801 Orthodontic metal band pusher

    Identifiers

    Type ID
    Primary 00840018600171